Registration Dossier
Registration Dossier
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EC number: 432-090-6 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 92/69/EEC, B14 (Ames test).
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium: TA1535, TA1537, TA98 and TA100. Escherichia coli: WP2uvrA-
- Metabolic activation system:
- Phenobarbitone/beta-naphthoflavone induced, rat-liver S9.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: Dimethyl sulphoxide
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Additional information on results:
- Observations:
Solvent control plates gave counts of revertant colonies
within the normal range.
All positive control chemicals gave increases in revertants,
either with or without the metabolising system as
appropriate, within expected ranges. Statistically
significant increases in the numbers of revertant colonies
was recorded for the bacterial strain TA100 both with and
without metabolic activation at the upper dose levels of the
substance. Smaller increases were also observed in tester
strain TA98. The substance was found to be mutagenic under
the conditions of this test. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
positive without metabolic activation
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